Biological specimen collectors and method

ABSTRACT

Biological specimen collectors, and more particularly devices for guiding such specimens into a container having a peripherally rimmed opening, one embodiment of which comprises a tube made from supple, elastic material, one end of which may be affixed to the outside of such a peripheral rim, in combination with a retaining band, whereby, after a specimen is guided into the container, the wall of the tube may stretched &#39;&#39;drum-head&#39;&#39; style over the opening to effect closure of the opening with the closure secured in position by means of the retaining band.

United States Patent 1191 Beach 1 Dec. 2, 1975 1 1 BIOLOGICAL SPECIMENCOLLECTORS AND METHOD [76] Inventor: Janet Beach, PO. Box 904,

Camden, Maine 04843 22 Filed: June 24,1974

21 Appl. No.: 482,161

52 US. Cl. 128/2 F; 4/110; 128/295;'

7 141/338 51 tm. cm A61B 10/00 [58] Field of Search 128/2 F, DIG. 5,295, 272, 128/275; 4/110; 141/337, 338

[56] References Cited UNITED STATES PATENTS 3,033,222 5/1962 Connolly128/295 3,459,174 8/1969 Walker 128/2 F 3,518,164 6/1970 Andelin etal.... 128/2 F X 3,579,652 5/1971 Ericson 4/110 Black 4/11() X 3,711,8711/1973 Sherin 4/110 3,815,646 6/1974 Coakley .1 141/337 PrimaryExaminerl(yle L. Howell Attorney, Agent, or FirmWilliam G. Rhines, Esq.

[57] ABSTRACT Biological specimen collectors, and more particularlydevices for guiding such specimens into a container having aperipherally rimmed opening, one embodiment of which comprises a tubemade from supple, elastic material, one end of which may be affixed tothe outside of such a peripheral rim, in combination with a retainingband, whereby, after a specimen is guided into the container, the wallof the tube may stretched drum-head style over the opening to effectclosure of the opening with the closure secured in position by means ofthe retaining band.

-6 Claims, 7 Drawing Figures Patent Dec. 2, 1975 Sheet 1 of3 3,923,040

fly 1 w U'.S. Patent -Dec.2, 1975 Sheet 2 of 3 D/ITE TIME 00c 70R f RUOMY I US. Patent Dec. 2, 1975 Sheet 3 of3 3,923,040

BIOLOGICAL SPECIMEN COLLECTORS AND METHOD BACKGROUND OF THE INVENTION DDFrequently it is desired to collect and store samples. Thus, forexample, when a child is delivered, it is common practice to sever theumbilical cord and to take a blood sample from it for test purposes.Another exam-. ple of a case where it frequently is desired totake-fluid samples from the human body is in the field .of urinalysis;still another example is a collection unit to receive tissue samples,commonly known as biopsy. However, certain practical problems have beenpresented in such cases. To begin with, typically the mouth of thecollection container has been small, making it very difficult to catchthe desired sample. Furthermore, the actual handling and use of thecontainer, as when its mouth is juxtaposed to an orifice of the body inthe process of collecting a sample, can cause contamination'of the tubein such a fashion that during subsequentexposure of the sample to thesurface, as when the sample is poured therefrom, it may becomecontaminated to such an extent as to effectively invalidate anyanalytical results of tests made on the sample. Additionally, in certaintypes of sample taking, apparatus available prior to the advent of thepresent invention wasnt adequate to permit the convenient taking ofrepresentative samples. Thus, in the field of urinalysis, it is knownthat the composition and density of the contents of the human bladdertends toward stratification. Thus, for example, heavy sediments collectat the floor of the bladder, to such an extent that if a sample weretaken comprised of the first portion evacuated, it rarely would berepresentative of the composition and/or concentrations of the materialactually being separated from the blood by the kidneys. For this reason,it is desirable that such samples be taken after a sufficient portion ofthe total evacuation has taken place to ensure that the sample collectedis of the more representative composition found at intermediate levelswhich have accumulated in the bladder.

Accordingly, it is an object of the present invention to provide aninexpensive and effective means for collecting and/or storing samples ofmaterials, particularly from the human body, such as blood, urine,tissue, sputum, feces, etc.

Another object of the present invention is to provide such a means whichcan be easily adapted for a variety of variant utilizations in materialscollection, such as the mid-stream collection of urine samples.

Still another object of the present invention is to provide a materialcollection means which will ensure against contamination of any sampleso collected by spurious or otherwise unwanted contaminants.

SUMMARY OF INVENTION Desired objects may be achieved through practice ofthe present invention, one embodiment of which comprises a flexible tubeaffixed to the mouth of a container, the other end of the tube beingretained open by means of a conical sleeve inserted therein; whereby,after the desired sample has been taken, part of the wall of the tubemay be stretched over the mouth of the tube and so retained in positionby means of an elastic band or other cap-like enclosure, after which theremainder of the tube with its insert may be severed off by cutting,

and discarded.

, DESCRIPTION OF FIGURES ment of the present invention illustrated inFIG. 1,

--FIG. 1 B illustrates a further step in the use of the embodiment ofthe present invention illustrated in FIG. 1,

FIG. 1 C illustrates a further step in the use of the embodiment of thepresent invention illustrated in FIG. 1, FIG. 2 illustrates anotherembodiment of the present invention,

FIG. 2 A illustrates a step in the use of the embodiment of the presentinvention illustrated in FIG. 2, and

FIG. 2 B illustrates a further step in the use of the embodiment of thepresent invention illustrated in FIG. 2.

DESCRIPTION. OF PREFERRED EMBODIMENTS Referring first to FIGQl, there isillustrated apparatus 10 comprising an embodiment of the presentinvention, comprising a container 12, which in this illustration is acentrifuge tube of known construction per se, a tube 14 with one of itsends 16 affixed to the mouth of the container 12 and the other of itsends 18 distended and retained open by means of an opening means 20. Asnoted above, the container in this illustration is a centrifuge tube ofknown per se design, which typically may be made from glass pyrex,plastic, or other material which is sterilizable, strong, and preferablytransparent, and inexpensive, although the present invention may also bepracticed in combination with a variety of other containers, includingtest tubes, flasks, beakers, and the like The tube 14 preferably is madefrom rather thin supple, elastic material, which can easily andeffectively be pulled over the opening of the container, preferably instretched condition, as a kind of drum-head, i.e., with its insidesubstantially flush with the entire top of the rim of the opening toensure against leakage of the contents from the container, and to ensureagainst leakage into the container of contaminants, germs, etc., whichmight contaminate the contents of the container as they are poured overthe lip. It should also be made from material chosen for substantialimpermeability and chemical inertness to the materials to which it is tobe exposed. Another desirable property for the tube, and of the caphereinafter described when such is utilized, is good mechanicalintegrity, so that it may be pierced, for example with a hypodermicneedle or a tube, to extract samples of material without having to breakthe sterile seal, with assurance that the hole so pierced will close upagain when the object is removed, and that it will not split open duringsuch processes. Latex has been found to be well suited as a tubematerial for such uses, but obviously a wide variety of rubbers andother elastomers, as well as plastics and other materials might also beso used.

Although it may be desirable in certain instances to bond'the end 16 ofthe tube 14 to the outside of the container 12 by use of adhesives orother fastening means, it is also possible to make the tube 14 of suchsufficiently small diameter that merely by virtue of its size andelasticity, a firm, tight, and substantially leakproof relationship willexist between the inner ,wall of the tube 14 and the outer wall of thecontainer 12. The opposite end 18 of the tube 14 is distended into awide orifice and retained open by means of opening means 20. Asillustrated, this opening means preferably is a tube in the form of aright section of a cone to provide for a funnel-like action in offeringa wide mouth for collection of material and channeling the flow of suchmaterial into the narrower tube 14 and thence into the container 12. Ofcourse, it might be cylindrical instead, or even of any of a variety ofcross-sections other than round, to adapt the apparatus to peculiaritiesof usage. Preferably, the opening means 20 is made from rather strong,fairly rigid material, such as plastic, paper, metal or the like,Generally plastic is preferred, however, because it is inexpensive,easily formed, sterilizable, inert to most chemical exposures, andpleasant appearing. The opening means 20 desirably has a ring 19 formedon the outside periphery, which serves as an anchor to hold the end 18of the tube 14 in position where it won't slip off of the means 20.

In use, material to be collected, such as blood, sputum tissue, urine,etc., is caused to enter the widemouthed opening means 20, and to passfrom there through the narrower tube 14 and into the container 12.Following such collection, as illustrated in FIG. 1 A, the tube 14 ispulled to one side so that a portion of the wall of the tube 14 liesflat, drum-head style, over the opening in the container 12, with theinside of that portion of the wall of the tube 14 flush withsubstantially all of the top of the opening. Then, as is furtherillustrated in FIG. 1 B, a means to retain the wall of the tube in suchsealing position, such as a ring, or a cap (notshown) of material whichpreferably is elastic, as a rubber band, is placed over the tube 14 andthe peripheral rim of the opening. Following this, the balance of thetube 14 and its associated opening means 20 man be severed off, as bycutting with a knife or scissors, and discarded, leaving the containeras illustrated in FIG. 16, with label 40 thereon, and ready to be placedin a centrifuge rack, or other processing, storage, or handlingcomponent, with its end sealed but still such that samples may bewithdrawn from the container by hypodermic needle, tube, or other means,without disturbing the biological state of either the sample or the tubeinterior.

It will be apparent that apparatus of the type herein described isideally suited to be sterilized and packaged in that condition, and thatin use, biologically or chemically foreign substances come into contactwith the contents of the material in its container either as it enters,is retained in, or is removed from the container since the sample seesonly sterilized surfaces. Thus, the analytical and biological integrityof the collected specimens may be preserved. It will also be apparentthat such apparatus may be made from constituents which are soinexpensive and effective, that throwaway packages which are bothtechnically and commercially feasible may be so produced.

FIG. 2 illustrates another embodiment of the present invention whichincludes, in addition to those elements comprising the embodimentillustrated in FIG. 1, an insert 24 in the form of a cup-like devicehaving a closed end 26 and side walls which may be made from materialsof the same type and selected on the same basis as those comprising theopening means 20, and the outside of which conforms substantially withthe inside 28 of the opening means 20. It also includes an annular ring25 positioned the outside circumference of the insert 24. This ring 25is particularly useful to keep the insert 25 from dropping too far intothe opening means 20 when it is positioned therein as hereinafterdescribed. It will be seen that the ring 25 corresponds to the flange 19on the opening means 20, and that the two pieces, i.e., the openingmeans 20 and the insert 24, may be produced with the same tooling; thebottom of the opening means 20 thereafter being removed. As illustratedin FIG. 2 A, this insert 24 may be positioned within the opening means20, thereby closing off access to the container 12 for a quantity ofmaterial equal in volume to the volume of the insert 24.

This embodiment is particularly useful in connection with such things asthe mid-stream collection and storage of materials for example, where itis desired to select out certain portions of the material to becollected from the rest of the material available. Thus, in urinalysis,for example, the first part of the sample taken which containsnon-representative proportions of sediments or other concentrations, maybe caught in the insert 24. After a sufficient amount of material 28 hasbeen passed to ensure that the composition has become representative,the insert 24 may be removed as shown in FIG. 2 B, without interruptionof the evacuation process, following which the material, in this caseurine, will flow through the opening means 20 and the tube 14 into thecontainer 12, from which point on, as is illustrated in FIGS. 1 Athrough 1 c. Such an embodiment is particularly useful, for example, incollecting urine samples from bed-ridden female patients.

It should be understood that the embodiments of the present inventionherein illustrated and described are by way of illustration but not oflimitation, and that other embodiments may be made by those skilled inthe arts without departing from the spirit or scope of this invention.

I claim:

1. A container for collecting and storing specimens of material havingan access opening with a peripheral rim on which is positioned one endof a tube for guiding specimens of material into said container, whichtube is made from supple elastic material which is impervious to thespecimens to be gathered, and a closure member comprising a closedelastic loop whose inside circumference in the unstretched state issmaller than the outside circumference of said tube positioned on saidrim with a portion of the wall of said tube stretched over said openingin drumhead fashion and with parts of said wall of said tube adjacentsaid portion retainably enclosed about said rim by the positioning ofsaid closure member thereon.

2. The device described in claim 1 including opening means positioned inthe end of said tube farthest from said container for retaining said endin open position, which opening means is in the form of a hollowstructure, the cross-sectional area of the top of which is smaller thanthat of the bottom, the top and bottom of which are open and the top ofwhich faces toward said container.

3. The device described in claim 2 including an insert means forremovable insertion into said opening means, the exterior lateral wallsof said insert means conforming substantially to the interior lateralwalls of said opening means, the end of said insert means which isfarthest within said opening means when said insert is affixed to theoutside of said rim, comprising the steps of stretching a portion of thewall of said tube over said rim so that it is in contact withsubstantially the entire lip of said rim, and securing such stretchedportion in said position by positioning a retaining means about theperiphery of said rim and over the parts of said wall which are adjacentto said portion.

1. A container for collecting and storing specimens of material havingan access opening with a peripheral rim on which is positioned one endof a tube for guiding specimens of material into said container, whichtube is made from supple elastic material which is impervious to thespecimens to be gathered, and a closure member comprising a closedelastic loop whose inside circumference in the unstretched state issmaller than the outside circumference of said tube positioned on saidrim with a portion of the wall of said tube stretched over said openingin drumhead fashion and with parts of said wall of said tube adjacentsaid portion retainably enclosed about said rim by the positioning ofsaid closure member thereon.
 2. The device described in claim 1including opening means positioned in the end of said tube farthest fromsaid container for retaining said end in open position, which openingmeans is in the form of a hollow structure, the cross-sectional area ofthe top of which is smaller than that of the bottom, the top and bottomof which are open and the top of which faces toward said container. 3.The device described in claim 2 including an insert means for removableinsertion into said opening means, the exterior lateral walls of saidinsert means conforming substantially to the interior lateral walls ofsaid opening means, the end of said insert means which is farthestwithin said opening means when said insert means is positioned withinsaid opening means being closed
 4. The device described in claim 2wherein said opening means is in the form of a conic section.
 5. Thedevice described in claim 3 wherein said opening means is in the form ofa conic section.
 6. A method of effecting closure of a biologicalspecimen collector container having a peripherally rimmed accessaperture therein and a collector tube made from supple, elastic,substantially impervious material which is affixed to the outside ofsaid rim, comprising the steps of stretching a portion of the wall ofsaid tube over said rim so that it is in contact with substantially theentire lip of said rim, and securing such stretched portion in saidposition by positioning a retaining means about the periphery of saidrim and over the parts of said wall which are adjacent to said portion.